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A Randomized Trial of Prednisolone, Itraconazole, or Their Combination in Allergic Bronchopulmonary Aspergillosis

Study acronym: PICA
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated February 28, 2025 (before its estimated June 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Primary completion date: Nov 2025 to Jun 2026
    • Study completion date: Mar 2026 to Jun 2026
    • Site details revised
    v3
  2. Start date changed from estimate of Dec 2023 to Dec 1, 2023v2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The investigators hypothesize that a combination of prednisolone and itraconazole would significantly reduce the exacerbation rate at one-year of patients with acute allergic bronchopulmonary aspergillosis (ABPA) compared to itraconazole or prednisolone monotherapy. In this study, 300 subjects aged ≥18 years with acute ABPA will be randomized to treatment with either prednisolone, itraconazole, or prednisolone plus itraconazole, all for four months each. After collecting baseline demographic, immunologic, and imaging data, the investigators will follow the patients every 2 months for the first two visits and then every four months for three visits. The primary outcome will be the proportion of subjects experiencing exacerbation (asthma or ABPA) 12 months after treatment completion.
Trial Details
NCT Number NCT06174922
Lead Sponsor Post Graduate Institute of Medical Education and Research, Chandigarh
Conditions
(from sponsor)		 Allergic Bronchopulmonary Aspergillosis
Related terms Aspergillosis, Allergic Bronchopulmonary
Enrollment 300 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov